Formulary back issues from February 2007:
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Feb 01, 2007; ... Approvable designations * Topical diclofenac solution, 1.5% w/w (Pennsaid, Nuvo) for the treatment of osteoarthritis of the knee * Retapamulin ointment, 1% (Attabax, GlaxoSmithKline) for the treatment of secondarily infected traumatic lesions * Lisdexamfetamine (Vyvanse, ...
New molecular entity
Feb 01, 2007; ... Invega Paliperidone JANSSEN Atypical antipsychotic approved for the treatment of schizophrenia Paliperidone, which is the major active metabolite of risperidone, belongs to the chemical class of benzisoxazole derivatives. The precise mechanism of action of this ...
First-time generic approvals
Feb 01, 2007; ... Methscopolamine tablets, 2.5 mg (equiv to Famine tablets) BOCA HARMACAL Methscopolamine tablets, 5 mg (equiv to Pmine Forte tablets) BOCA PHARMACAL Bupropion extended-release tablets, 150 and 300 mg (equiv to Wellbutrin XL extended-release ...
New indications
Feb 01, 2007; ... Invanz Ertapenem for injection MERCK Antibiotic approved for the prophylaxis of surgical site Infection following elective colorectal surgery Ertapenem, a sterile, synthetic, parenteral, 1-beta methyl-carbapenem, is structurally related to heta-lactam antibiotics ....
New formulation
Feb 01, 2007; ... Ability Aripiprazole injection for intramuscular use BRISTOL-MYERS SQUIBB/OTSUKA intramuscular Injectable formulation of atypical antipsychotic approved for the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed This agent's ...
actions in brief
Feb 01, 2007; ... FDA An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. FDA approved calcium hydroxylapatite (Radiasse, BioForm Medical) for the long-lasting correction ...
Cabergoline, pergolide linked to cardiac-valve regurgitation
Feb 01, 2007; ... A COLLECTION OF THE LATEST DRUG SAFETY NEWS, NOTICES, LABELING CHANGES, AND DRUG AVAILABILITY ISSUES Concern over possible valvulopathy with the use of certain ergot-derived dopamine agonists is further supported by 2 studies published in the New England Journal of Medicine (NEJM) ...
Long-term use of acid-suppressing drugs may be associated with increased risk of hip fracture
Feb 01, 2007; ... In a large, nested case-control study published in the Journal of the American Medical Association (JAMA), proton pump inhibitor (PPI) use was demonstrated to be associated with a 44% to 165% increase in the risk of hip fracture in patients aged >50 years. The authors remarked: "We ...
Strategies for the management of insomnia: An update on pharmacologic therapies
Feb 01, 2007; ... Abstract Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as ...
Arformoterol: The first nebulized long-acting beta^sub 2^-adrenergic agonist
Feb 01, 2007; ... Abstract Bronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the ...
Extended dual antiplatelet therapy demonstrated to improve post-DES implantation outcome
Feb 01, 2007; ... The duration of dual antiplatelet therapy (aspirin plus clopidogrel) following drug-eluting stem (DES) implantation has been a source of much recent debate. FDA currently recommends either 3 or 6 months of clopidogrel therapy following DES implantation, depending on the type of stent ...
FIT versus FLEX: Weighing the benefits of extending bisphosphonate therapy beyond 5 years
Feb 01, 2007; ... A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone ...
Aspirin may reduce the risk of newly diagnosed adult-onset asthma
Feb 01, 2007; ... A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%. These results were published in the American ...
Tolterodine ER plus tamsulosin demonstrates benefit in men with lower urinary tract symptoms, overactive bladder
Feb 01, 2007; ... Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha^sub 1^-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and ovcractive bladder, according to a large-scale, randomized, ...
Rifaximin considered as possible treatment for IBS
Feb 01, 2007; ... Rifaximin has demonstrated global improvement of the symptoms of irritable bowel syndrome (IBS) in patients for ≤10 weeks after the discontinuation of therapy. Rifaximin is a nonabsorbed (≤0.4%), broad-spectrum antibiotic that was approved by FDA in 2004 for travelers' ...
Treatment with metformin may lead to vitamin B12 deficiency in patients with diabetes
Feb 01, 2007; ... Though metformin has become a popular treatment for patients with diabetes mellitus, the risk of vitamin B12 malabsorption has not gone undocumented. A nested case-control study of 155 patients with diabetes and metformin-related vitamin B12 deficiency and 310 control patients demonstrated such ...
Antipsychotics demonstrate minimal benefit in treatment of psychosis, aggression, agitation in patients with AD
Feb 01, 2007; ... Adverse events associated with the use of atypical antipsychotic medications in the management of psychosis, aggression, and agitation in patients with Alzheimer's disease (AD) may outweigh any benefit the treatments provide, according to a double-blind, placebo-controlled study published in the ...
Sleep disturbance associated with SSRI use in older women
Feb 01, 2007; ... A cross-sectional study of selective serotonin reuptaka inhibitor (SSRI) use by community-dwelling older women aged ≥ 71 years with or without depression demonstrated that SSRI use in that population was strongly associated with sleep disturbance. The study, which relied on data collected ...
AGA issues consensus statement on the use of NSAIDs
Feb 01, 2007; ... The American Gastroenterological Association (AGA) has issued a consensus statement on the safe and efficacious use of nonsteroidal anti-inflammatory drugs (NSAIDs), including nonselective, nonsteroidal anti-inflammatory drugs (nsNSAJDs), cyclooxygenase-2 enxyme inhibitors (coxibs), and aspirin ...
A critical look at prescription drug direct-to-consumer advertising
Feb 01, 2007; ... Direct-to-consumer advertising (DTCA) of prescription drugs has been a source of debate since its US approval by FDA in 1997. A primary source of debate among experts is the methods advertisers use to attempt to influence the consumer and the consumer's subsequent reaction. Despite the ...
New diagnostic tool aids in pathogen identification; kiosks in doctors' offices provide generic drug samples
Feb 01, 2007; ... HOW HIGH-TECH ADVANCES AND APPLICATIONS ARE IMPACTING HEALTH-SYSTEM AND MANAGED-CARE PHARMACY Researchers at the Infectious Disease Laboratory at Columbia University Mailman School of Public Health and the World Health Organixation (WHO) Global Laboratory Network have developed a new ...
FDA releases proposals for PDUFA IV; federal report addresses cost of drug development
Feb 01, 2007; ... FEDERAL AND STATE GOVERNMENT ACTIONS AND THEIR IMPACT ON DRUG DECISION-MAKERS A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is ...